BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Baxter
Julphar
UBS
Moodys
Colorcon
Mallinckrodt
Fish and Richardson
Dow
US Army
Accenture

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078601

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NDA 078601 describes ROPIVACAINE HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Aurobindo Pharma Ltd, Hospira, Navinta Llc, and Sagent Strides, and is included in five NDAs. It is available from five suppliers. Additional details are available on the ROPIVACAINE HYDROCHLORIDE profile page.

The generic ingredient in ROPIVACAINE HYDROCHLORIDE is ropivacaine hydrochloride. There are thirteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.
Summary for 078601
Tradename:ROPIVACAINE HYDROCHLORIDE
Applicant:Navinta Llc
Ingredient:ropivacaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078601
Ingredient-typeAmides
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 078601
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 078601 ANDA Sandoz Inc 0781-3140 0781-3140-14 5 CARTON in 1 BOX (0781-3140-14) > 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3140-30) > 30 mL in 1 VIAL, SINGLE-DOSE
ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 078601 ANDA Sandoz Inc 0781-3142 0781-3142-14 5 CARTON in 1 BOX (0781-3142-14) > 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3142-80) > 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength150MG/30ML (5MG/ML)
Approval Date:Jul 17, 2014TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength200MG/20ML (10MG/ML)
Approval Date:Jul 17, 2014TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Queensland Health
Johnson and Johnson
US Department of Justice
Merck
Baxter
Fuji
UBS
AstraZeneca

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